MARGARET M. HECKLER, SECRETARY OF HEALTH AND HUMAN SERVICES,
APPLICANT v. LARRY LEON CHANEY, ET AL.
No. A-761
In The Supreme Court Of The United States
October Term, 1983
Application For A Stay Pending Petition For a Writ of Certiorari To
The United States Court of Appeals For The District of Columbia
Circuit
Application For A Stay Pending Petition For A Writ of Certiorari To
The United States Court of Appeals for The District of Columbia
Circuit
Pursuant to Rules 43 and 44 of the Rules of this Court and 28
U.S.C. 2101(f), the Solicitor General, on behalf of the Secretary of
Health and Human Services, applies for a stay of the mandate of the
United States Court of Appeals for the District of Columbia Circuit
pending the filing and disposition of a petition for a writ of
certiorari in this case.
Five states carry out the death penalty by administering lethal
injections of drugs. A sharply divided court of appeals has in effect
directed the Food and Drug Administration (FDA) -- an agency devoted
to insuring that consumers are protected against unsafe or ineffective
foods and drugs -- to prohibit the enforcement of these capital
punishment statutes until it has been demonstrated to the agency that
these drugs are "'safe and effective' as a means of human execution."
Attachment A at 3. The court of appeals reversed the judgment of the
district court that the FDA's decision not to initiate enforcement
action in this area was not reviewable. The court of appeals' mandate
requires the FDA to explain its inaction consistently with the court
of appeals' broad interpretation of the FDA's responsibility in this
area. Attachment A at 34. If such an explanation is not "promptly
forthcoming," the court of appeals effectively required that the
district court order FDA enforcement action. Id. at 34 & n.47.
As explained more fully below, the court of appeals' judgment
sanctions unprecedented judicial interference in the decision-making
processes of the Food and Drug Administration. Moreover, in view of
the expedition on the part of the district court clearly contemplated
by the court of appeals, issuance of the mandate may result in a
district court order requiring agency enforcement action before this
Court can review the court of appeals' decision. /1/
STATEMENT
This case was brought by prison inmates sentenced to death in Texas
and Oklahoma. They had petitioned the FDA to prohibit the enforcement
of state capital punishment statutes on the ground that the states
proposed to administer lethal injections of drugs that had been
approved by the FDA as safe and effective for other purposes but had
not been so approved for human execution. Plaintiffs asserted that
the use of these drugs to carry out capital punishment violated the
"misbranding" provisions of the Food, Drug, and Cosmetic Act (FDCA),
21 U.S.C. 331(k), 352. They requested the FDA, among other things, to
"(a)dopt a policy and procedure for the seizure and condemnation from
prisons or state departments of correction of drugs which are destined
or held for use as a means of execution" and to recommend the criminal
prosecution of prison officials and others who "knowingly buy,
possess, (sell) or use drugs for the unapproved use of lethal
injections." Attachment A at 6.
The FDA declined to take the requested enforcement actions as a
matter of its enforcement discretion. Noting the uncertainty in the
case law regarding the FDA's authority to regulate the unapproved use
of approved drugs, the FDA decided not to initiate enforcement action
in the absence of "a serious danger to the public health or a blatant
scheme to defraud."
Plaintiffs then brought this suit for injunctive and declaratory
relief. The district court dismissed the complaint on the ground that
the enforcement decisions of an agency are not subject to judicial
review.
On appeal, a divided panel of the court of appeals vacated the
district court's judgment and held that the FDA's decision was subject
to judicial review. The court reasoned that all agency action,
including a decision not to initiate enforcement proceedings, is
presumptively reviewable except in those rare situations "where the
governing statute is 'drawn in such broad terms that in a given case
there is no law to apply.'" Attachment A at 16-19. The court found
"law to apply" in this case in the preface to an FDA rule proposed for
notice and comment in 1972 but never promulgated. The court held that
the FDA's reasons for declining enforcement were irrational in light
of that preface, and it therefore directed the district court "to
order the agency to fulfill its statutory function." Id. at 34. The
court noted (ibid.) that "(w)e must be prepared to compel FDA to take
action with respect to the (plaintiffs') prayer for relief where an
acceptable explanation of (FDA's) inaction is not promptly
forthcoming." /2/
In dissent, Judge Scalia pointed out that "(a)n agency's decision
to refrain from an investigation or an enforcement action is generally
unreviewable." Attachment A at 1 (dissenting op.). He noted that the
"policy statement" on which the majority relied had no binding legal
effect and that, even if it were binding, it was "full of flexible
terms, the precise application of which was obviously intended to be,
and could properly be, left to the discretion of the agency -- for
example whether an unapproved use has become 'widespread.'" Id. at 9.
Judge Scalia concluded that the majority's decision constituted "a
clear intrusion upon powers that belong to Congress, the Executive
Branch and the states" (id. at 1).
By a five-to-five vote, the court of appeals denied the
government's suggestion for rehearing en banc. Attachment B. In a
statement joined by Judges Wilkey, Bork, and Starr, Judge Scalia
stressed the significance of the holding of this case to "the
enforcement authority of all federal agencies." He stated that the
panel's finding of a "general presumption of reviewability" of
enforcement decisions "distorts the law and usurps the authority of
the Executive Branch."
On March 14, 1984, the court of appeals denied the government's
second consent motion for a 30-day stay of mandate to permit the
government to petition for review by this Court. The court ordered
the mandate to issue on March 21, 1984.
ARGUMENT
The court of appeals' judgment requires the district court to
interfere with the enforcement priorities of the FDA and to insert
itself into the controversial debate concerning capital punishment.
The Solicitor General accordingly has authorized the filing of a
petition for a writ of certiorari. We respectfully request that the
court of appeals' mandate be stayed pending this Court's disposition
of the case.
In deciding whether to grant a stay pending certiorari, the Court
or Circuit Justice ordinarily regards it as appropriate "to determine
whether four Justices would vote to grant certiorari, to balance the
so-called 'stay equities', and to give some consideration as to
predicting the final outcome of the case in this Court." Heckler v.
Lopez, No. A-145 (Sept. 9, 1983) (Rehnquist, Circuit Justice), slip
op. 3. See also id. (Brennan, J., dissenting), slip op. 2; Heckler
v. Blankenship, No. A-589 (Jan. 26, 1984) (O'Connor, Circuit Justice),
slip op. 2. In this case those factors clearly weigh in favor of a
stay.
1. There is a strong probability that this Court will grant
certiorari in this case. The court of appeals' holding regarding
judicial review of the FDA's discretionary enforcement decisions is in
direct conflict with the Eighth Circuit's decision in National Milk
Producers Federation v. Harris, 653 F.2d 339 (1981). /3/ The decision
below completely reverses the prior consistent case law and would
appear to permit court review in a great many instances in which
regulatory agencies decline to initiate enforcement actions. Compare,
Southern Railway Co. v. Seaboard Allied Milling Corp., 442 U.S. 444
(1979); Kixmiller v. SEC, 492 F.2d 641, 645 n.27 (D.C.Cir. 1974)
(collecting cases). Such review would substantially compromise the
ability of enforcement agencies to marshal their resources
effectively.
The court of appeals' decision will also have exceptionally
significant practical consequences that weigh strongly in favor of
review by this Court. This decision, if not reversed, will require
the FDA to intervene in a highly controversial area far removed from
its proper responsibilities. This will hamper the FDA's performance
of its intended mission to protect the consuming public from dangerous
and misbranded drugs. Furthermore, the decision below is likely to
interfere with state enforcement of capital punishment statutes that
satisfy Eighty Admendment standards. In those states that, for
humanitarian reasons, have adopted lethal injections as the method of
capital punishment, the court of appeals' decision may thwart
enforcement of capital punishment statutes or result in the carrying
out of executions by other potentially more painful means.
2. a. Not only is certiorari likely to be granted, but there is
also a strong probability that this Court will reverse the judgment of
the court of appeals. The effective functioning of administrative
agencies would be seriously impaired by judicial review of
administrative enforcement decisions. In deciding how to employ their
limited enforcement resources, agencies generally concentrate on those
efforts that are most needed and offer the greatest changes of
success. Such choices are necessarily based in large measure on
policy considerations and discretion. Judicial review in this area is
likely to result in the substitution of the preferences of the
judicial branch for those of the executive. For this reason,
enforcement decisions of regulatory agencies have been held to be
unreviewable, absent special circumstances. See Judge Scalia's
dissent, Attachment A at 1-8. The court's decision in this case is
flatly inconsistent with this settled principle of administrative law.
The Administrative Procedure Act, 5 U.S.C. 701(a)(2), provides that
final agency action is not subject to judicial review if it is
"committed to agency discretion by law." This bar to judicial review
applies in those instances where the governing statute is "'drawn in
such broad terms that in a given case there is no law to apply.'"
Citizens to Preserve Overton Park v. Volpe, 401 U.S. 402, 410 (1971)
(quoting S. Rep. 752, 79th Cong., 1st Sess., 26 (1945)).
This is a case in which there is "no law to apply." The FDCA, like
most statutes granting enforcement powers to administrative agencies,
does not set forth or even suggest standards by which the FDA is to
determine whether and when it shall engage in enforcement activity.
/4/ Thus, even if the states' use of drugs not approved for lethal
injections constituted a technical violation of the FDCA, judicial
review would not be available under the APA. As this Court has
stated, the Commissioner of Food and Drugs possesses a "broad
discretion -- broad enough undoubtedly to enable him to perform his
duties fairly without wasting his efforts on what may be no more than
technical infractions of the law." United States v. Sullivan, 332 U.S.
689, 694 (1948).
For its contrary conclusion, the court of appeals relied upon what
it termed the FDA's "policy statement." The court contended that this
statement "made law to govern and guide (the FDA's) discretion in
regulating the unapproved use of approved drugs" and thereby provided
standards against which the court could determine whether the FDA's
refusal to engage in enforcement activities was an abuse of
discretion. Attachment A at 23. The court characterized this
"statement" as a rule, claiming that the FDA has asserted the
"statement" to be "binding and to have substantive effect." Ibid.
As Judge Scalia noted in dissent, however, the FDA's policy
statement was merely the preamble to a proposed rule that was never
adopted and thus had no binding effect. Attachment A at 10-19
(dissenting op.). Not every informal, tentative opinion ventured by
an agency constitutes a binding policy that may be enforced by the
courts. Moreover, as the dissent observed, the policy statement is
full of flexible terms, the precise applicability of which was
obviously intended to be left to the agency. Attachment A at 9
(dissenting op.). In addition, a subsequently enacted FDA regulation
clearly stated that the decision whether to initiate enforcement
proceedings is a matter committed to the discretion of the agency. 21
C.F.R. 10.45(d)(2)(i).
For these reasons, it is clear that the FDA's decision not to
initiate enforcement action in this case was committed to agency
discretion by law and therefore was not judicially reviewable.
b. Even if the FDA's decision were reviewable, it nonetheless
should have been upheld. Where statutes authorize judicial review of
administrative enforcement decisions, the scope of review is limited
to determining whether the agency has stated a rational basis for its
decision. Dunlop v. Bachowski, 421 U.S. 560, 573 (1975). That
standard was easily met here. First, the FDA had a serious basis for
uncertainty concerning its jurisdiction under the FDCA to regulate the
activity in question. See Judge Scalia's dissent, Attachment A at
14-18; United States v. Evers, 643 F.2d 1043 (5th Cir. 1981). Surely
when Congress enacted the FDCA it could never have contemplated such
FDA intervention.
Furthermore, the FDA acted reasonably in relying in the alternative
on the absence of a "serious danger to the public health." As the
dissent below stated (Attachment A at 12 (dissenting op.) (emphasis in
original)):
the public health interest at issue is not widespread death or
permanent disability, but (at most) a risk of temporary pain to
a relatively small number of individuals * * * . Moreover, it
is not a matter of pain verses no pain, but rather pain of one
sort substituted for pain of another -- and in all likelihood
substitution of a lesser pain, since that is the principal
purpose of the lethal injection statutes.
Thus, even if the FDA's decision not to initiate enforcement
proceedings were judicially reviewable, that decision was soundly
based and should not have been disturbed.
3. Issuance of the mandate during the pendency of proceedings in
this Court will in all likelihood result in irreparable injury to the
public interest. The court of appeals' opinion states that "(w)e must
be prepared to compel FDA to take action with respect to the prayer
for relief where an acceptable explanation of (FDA's) inaction is not
promptly forthcoming." Attachment A at 34. And the court of appeals
has already rejected as a matter of law the several reasonable bases
asserted by the FDA for not regulating the states' administration of
capital punishment. See id. at 30-33. While there may be additional
sound reasons for not entering upon such a regulatory effort, it is
unlikely, in light of the court of appeals' decision, that such
additional grounds will be found "acceptable," and the court of
appeals has indicated that the district court must act expeditiously
if an "acceptable" basis for the agency's decision is not "promptly
forthcoming." Id. at 34. It is therefore very likely that issuance of
the mandate will result in imminent and serious judicial interference
with the proper work of the FDA, as well as with the enforcement of
constitutional state capital punishment statutes.
The FDA has the task of protecting the consuming public from
misbranded and adulterated drugs. Attempting to regulate state
enforcement of capital punishment will waste the FDA's limited
administrative resources and distract the agency from its proper
responsibilities. Such unprecedented judicial interference with an
agency's enforcement priorities and the exercise of its expert
discretion should not be permitted absent a ruling from this Court.
Moreover, the proceedings contemplated by the court below may well
cause substantial federal intrusion into the legitimate province of
the states. Again, this untoward result should not occur absent a
ruling from this Court.
If this Court grants certiorari, the case will not be heard and
decided until next Term. Accordingly, if the mandate is not stayed,
the FDA will in all likelihood be required in the interim to regulate
the method of capital punishment used in several states. As Judge
Scalia pointed out in dissent (Attachment A at 18 (dissenting op.):
(The FDA) was properly refusing to permit its powers and the
laws it is charged with enforcing from being wrongfully enlisted
in a cause that has less to do with assuring safe and effective
drugs than with preventing the states' constitutionally
permissible imposition of capital punishment. This court should
have done the same.
While issuance of the mandate will cause serious harm, respondents
have never asserted any urgent need for issuance of the mandate.
Indeed, they consented to the stay motion that the court of appeals
denied.
CONCLUSION
The mandate of the court of appeals should be stayed pending the
timely filing and disposition of a petition for a writ of certiorari.
Respectfully submitted.
REX E. LEE
Solicitor General
MARCH 20, 1984
/1/ We have attached hereto copies of (a) the court of appeals'
October 14, 1983, opinion (Attachment A) (718 F.2d 1174); (b) the
court of appeals' January 17, 1984, order denying the government's
petition for rehearing and suggestion of rehearing en banc (Attachment
B) (724 F.2d 1030); and (c) the court of appeals' March 14, 1984,
order denying the government's motion to stay the mandate until March
26, 1984 (Attachment C).
/2/ Although the court of appeals acknowledged that "the state may
take the life of a person as punishment" and that the "FDA is not
responsible for the execution of these prisoners," the court observed
that the "FDA's impermissible refusal to exercise enforcement
discretion over the use of drugs for lethal injection * * * may also
implicate the Eighth Amendment's prohibition of cruel and unusual
punishment" (Attachment A at 35-36).
/3/ National Milk Producers Federation concerned a petition by
dairy producers to the FDA, requesting that the FDA initiate
enforcement proceedings against persons alleged to be selling
misbranded "cheese substitutes" in interstate commerce contrary to the
FDCA. The Eighth Circuit held (653 F.2d at 343) that:
The executive branch and its departments enjoy a discretion in
the initiation of * * * enforcement * * * actions limited only
by constitutional strictures and relevant statutory directives.
Because the FDCA does not mandate enforcement actions, the court
concluded that a "complaint which seeks the initiation of
investigative, enforcement, or prosecutorial proceedings fails to
state a claim upon which * * * relief can be granted." Id at 344.
/4/ Nothing in the FDCA sets standards for the initiation of FDA
enforcement proceedings. The mandatory language in the penalty
provision of the FDCA, 21 U.S.C. 333(a), to which the court of appeals
referred (Attachment A at 24 n.29), is no different from that of a
typical criminal code provision. See Judge Scalia's dissent,
Attachment A at 9 (dissenting op.). The only provision of the FDCA
regarding the FDA's responsibility to initiate enforcement proceedings
is 21 U.S.C. 336, which provides:
Nothing in this Act shall be construed as requiring the
Secretary to report for prosecution * * * minor violations of
this Act whenever he believes that the public interest will be
adequately served by a suitable written notice or warning.
APPENDIX